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GB19082-2023
Disposable protective clothing for medical use
医用一次性防护服
GB 19082-2023 — действующий обязательный национальный стандарт Китая: Disposable protective clothing for medical use. Отрасль: Пищевая. Тема: Безопасность продукции. Дата вступления в силу: 1 дек. 2025 г..
Применимость зависит от продукции, схемы сертификации, уведомлений компетентных органов и переходных правил. Закажите перевод или проверьте источник, прежде чем использовать эту запись в решениях по соответствию.
Обзор требований
Этот обзор пока доступен только на английском языке.
Область применения
This standard applies to disposable protective clothing for medical use intended for personnel in medical institutions during medical and disease prevention work. It covers scenarios with potential exposure to infectious blood, body fluids, secretions, and airborne particles. This standard is mandatory for all manufacturers of medical protective clothing entering the Chinese market. It does not apply to protective clothing used in non-medical environments where risk assessment by the user is required.
Технические требования
The standard specifies comprehensive requirements for material physical properties, including tear strength, tensile strength, puncture resistance, seam strength, abrasion resistance, and flex cracking resistance, categorized into performance levels. It outlines strict criteria for liquid barrier performance, covering water penetration resistance, surface moisture resistance, and resistance to synthetic blood penetration. The standard mandates barrier performance against infectious agents, requiring testing for resistance to bacteriophage penetration and setting minimum particle filtration efficiency (PFE) for non-oily particles. Additional requirements include water vapor transmission rate (comfort), flammability, antistatic properties, biocompatibility, microbial limits, and ethylene oxide residue (if applicable). Manufacturers must ensure their products meet these minimum performance thresholds.
Методы испытаний
Testing involves various standardized methods, referencing standards like GB/T 3917.3 for tear strength and GB/T 24218.3 for tensile strength. Liquid barrier and infectious agent barrier tests utilize methods from GB/T 4744, YY/T 0700, and YY/T 0689 to evaluate resistance to synthetic blood and bacteriophage penetration. Microbial testing follows the Pharmacopoeia of the People's Republic of China (2020 Edition), and biocompatibility is assessed according to GB/T 16886.1.
Частые вопросы
What products are regulated under GB 19082-2023?
It regulates disposable protective clothing for medical use designed for healthcare workers exposed to infectious agents.
Are there any updates from the previous version of GB 19082?
Yes, the 2023 version replaces the 2009 version, adding requirements for tear strength, puncture resistance, seam strength, and biocompatibility, while removing size specifications and skin irritation requirements.
Does GB 19082-2023 specify requirements for particle filtration efficiency?
Yes, the standard requires that the material and seams of the protective clothing have a particle filtration efficiency of not less than 70% for non-oily particles.
The summary above provides a high-level overview of GB 19082-2023. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 19082-2023 today to access all detailed parameters, tables, and testing procedures.
Подсказки по применимости
- Тип
- Продукция
- CCS
- C48
- ICS
- 11.100
- Компетентное ведомство
- National Medical Products Administration
- Технический комитет
- National Standardization Working Group on Medical Protective Devices
Связи
Заменяет:GB 19082-2009